This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. and arguably just as safe. The FDA can prevent the importation of such drugs – but the agency is actually encouraged by law not to do so if the import is for personal use only. It’s also a story about consumers and their providers navigating conflicting public information about buying less expensive medicines online from foreign countries.
A friend of mine, who has very difficult to control cholesterol, was prescribed Livalo, an FDA-approved brand of the drug pitavastatin. Let’s call him John. With his insurance, Livalo still costs John about $310 for a three-month supply – about 90 pills. He doesn’t want to pay that much if he can help it. John knows about our company, PharmacyChecker. He went to our site to discover that brand-name Livalo (pitavastatin) costs only $90 for a three-month supply at the lowest-cost PharmacyChecker-accredited international online pharmacy: a savings of 71%. That wasn’t enough to convince John to move forward with the purchase. Why not? That brand-name pitavastatin, sold in Turkey, is sold under the name Alipza – not Livalo.
John’s doctor was skeptical of drugs bought online from other countries. Is the drug safe? Is it counterfeit? Is it really the same? We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research. Other medical professionals, however, are subject to the same scare tactics as consumers, ones perpetrated by drug company-funded organizations. In fact, medical professionals are targeted by such groups’ education programs. For example, the Alliance for Safe Online Pharmacies, which has received lots of money from drug companies, and the Federation of State Medical Boards teamed up to offer a “continuing education program” for pharmacists and physicians. The stated goal is to teach them: “What Providers Need To Know.” The gist is to inform them that 1) buying drugs on the Internet can be dangerous; and 2) the only way to stay safe is by sticking to U.S. pharmacies.
So, John was skeptical, even though he knows what we do at PharmacyChecker, which is accrediting only the safest international online pharmacies. In fact, when I heard about the price differentials, I became skeptical, too – but in a different sense. I know the medicines sold by PharmacyChecker-accredited online pharmacies are lawfully-manufactured, safe and effective drugs. That was not my concern. John wanted to know if these prices were for the “same” drug. That word “same” is hard to answer when it comes to prescription drugs. For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” That response is related to well-made generic drugs – not those discovered as inferior due to fraud or poor manufacturing, which is a serious problem. The generic may very well work the same way as the brand, but it almost always looks different, comes in different packaging, and, while the active pharmaceutical ingredient is the same, inactive ingredients are usually different. And that’s in the same country.
Approved drugs with the same active pharmaceutical ingredients but sold in different countries are often not the exact same. Sometimes they are. Sometimes they are not. This includes brand-name drugs created by the same pharmaceutical company. The exact same FDA-approved drugs are sold in America and other countries, but with different labels. In many other cases, there are foreign versions of FDA-approved drugs sold by the same drug companies.
What do I tell John?
The retail price of 90 pills of Livalo without insurance is about $1,000 (far more than John pays with his insurance: about $310). That would make it over 10 times more expensive than the $90 brand Alipza. That made me consider the possibility that there was an error on our site, and we were showing the generic version price, which is available in India. After some research we found out that it is really the brand, Alipza not Livalo. Alipza is the name for branded pitavastatin in many European countries and in Turkey. The drug company responsible for marketing both Livalo and Alipza is called Kowa Pharmaceuticals, a Japanese company.
So, are these the “same” drug?
I believe the answer is an unequivocal yes: Livalo and Alipza are the exact same.
They have the exact same active ingredient, pitavastatin – and appear to have the exact same inactive ingredients. They were both approved by the world’s top regulatory authorities for safety and efficacy: Livalo by the U.S. FDA and Alipza by the United Kingdom Medical and Health Product Regulatory Authority. Interestingly, MHRA approved the marketing of Kowa’s pitavastatin under both Livalo and Alipza in the application’s approval.
Here’s a difference between Livalo and Alipza besides the name
Livalo, sold in the U.S., is made in Japan or Ohio. The Alipza is licensed to Italian drug company Recordati and manufactured in France by Pierre Fabre Médicament Production. Should that cause concern? No. France, according to the FDA, is recognized as having similarly strict pharmaceutical regulations to the U.S., per a mutual recognition agreement (MRA) signed in 2017. Not that this MRA is necessary for us to have confidence in France’s regulatory capabilities. The FDA’s counterpart, called The French National Agency for Medicines and Health Products Safety, was known to properly regulate drug manufacturing before the MRA. The MRA is proof that the FDA’s position is that drugs manufactured in France can meet U.S. requirements. According to the FDA:
“Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements.”
But we can drill down further here. The French drug manufacturing company itself is registered directly with the U.S. FDA: PIERRE FABRE MEDICAMENT PRODUCTION. This is the company that makes the Alipza, which has the exact same active ingredient and inactive ingredients as Livalo. The Alipza sold in Turkey is manufactured by that same FDA-registered company – Pierre Fabre Medicament Production – under license Recordati Ilac Sanayi ve Ticaret A.S.
It is the same Alipza that John was looking at: available for $90 for a three-month supply, over 90% less than Livalo’s price for uninsured Americans, 70% less for insured Americans like John.Tagged with: Alipza, livalo